FDA committee to meet regarding painkiller Entereg

WASHINGTON The Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee will meet in January to discuss GlaxoSmithKline and Adolor’s opioid receptor antagonist Entereg. The drug is designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects.

The drug has been delayed due to safety concerns by the FDA. The agency requested data from clinical trials studying Entereg in patients with cancer pain and opioid-induced bowel dysfunction, as well as results from trials testing the drug in combination with hydrocodone and acetaminophen and two-year carcinogenicity data from preclinical studies.

GSK and Adolor had suspended the drug’s development after safety concerns, including cardiovascular adverse events, skin cancers and bone fractures, surfaced in clinical trials.

Wyeth and GSK may see competition in pediatric vaccines

Pharma giants Wyeth and GlaxoSmithKline are set to go head to head with their competing childhood vaccines, but Wyeth dismissed any worries about the newcomer to the vaccine playground.

Wyeth’s Prevnar will remain a key sales driver for the company but would not be hindered by Glaxo’s Synflorix, said Emilio Emini, the U.S. group’s head of vaccine research and development, on Tuesday.

Prevnar, a vaccine for infants and children to prevent certain invasive pneumococcal diseases, is active against seven types of streptococcus pneumonia, which together account for some 80 percent of illnesses, Reuters reported Tuesday.

Glaxo’s Synflorix, which a company spokeswoman said remained on track for submission to European regulators by the end of 2007, targets 10 types, and even prevents inflammation of the middle ear.

But Emini said Synflorix was incomparable to the new version of Prevnar.

“Essentially, it is a direct equivalent of the original Prevnar,” he said in an interview with Reuters on the sidelines of the FT Global Pharmaceutical and Biotechnology Conference. “If you look at the residual 20 percent of disease (not addressed by Prevnar) and ask how much is covered by the GSK 10-valent vaccine, it’s actually a small percentage. How much is covered by Prevnar-13? It’s over 60 percent,” Emini said.

Wyeth intends to submit a new version of Prevnar, active against 13 strains, to both European and U.S. regulators by the beginning of 2009.

The original version of the vaccine was introduced in 2000. Third-quarter sales of Prevnar were up 24 percent from a year earlier at $634 million.

Biomira to make move to U.S. under new name

EDMONTON, Canada Biomira shareholders have approved a plan to move the company to the U.S. and to change its name to Oncothyreon Incorporated. Oncothyreon will be the parent corporation of a successor company of Biomira and its subsidiaries, according to Canada.com.

The biotech company, which focuses on cancer treatment, currently has a few drugs in its pipeline including Stimuvax, which it is developing with Merck to treat non-small cell lung cancer. That drug is currently in a Phase III clinical trial. The next drug that is furthest along in development is a small molecule called PX-12, which is a drug used to treat pancreatic cancer and is currently in a Phase II trial.

“We are very pleased to have received the strong support of our shareholders for our relocation and the revision of our capital structure,” chief executive officer Robert Kirkland said. The shareholders will receive one-sixth of a share of common stock of Oncothyreon in exchange for each Biomira share. The new company will be based in Seattle.

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The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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